FDA.reportPublic FDA data

GE HEALTHCARE FINLAND OY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96101053002806783GE HEALTHCARE FINLAND OY1N2026-01-01KUORTANEENKATU 2 HELSINKI Uusimaa FI FIN-00510

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266201397809591K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESMLD1999-11-01
266201672635337K981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1DRT1998-11-03
266201915753094K931422DELTATRAC(TM) II METABOLIC MONITORBZL1993-11-24
266201205918838K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSCAN1992-05-27
266202023957244K904355CARDIOCAP II TM CH-RESP MONITORSDPS1991-05-23
266202033703436K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MMHX2026-09-01
266201996925424K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX2026-08-28
266202034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
266201743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
266201175583964K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™MWI2023-08-11
266201423213164K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)MHX2023-04-06
266201771137171K213363CARESCAPE B450, E-musbMHX2022-04-13
266201171121298K213336Carescape B850, E-musbMHX2022-04-13
266201481395238K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHX2022-04-12
266201513812715K213181CARESCAPE B650, E-musbMHX2022-04-13
266201510858541K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessoriesCCK2021-10-21
266201540286742K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESMHX2020-03-29
266201202861869K191323Carescape B850MHX2020-01-29
266201254482842K191322E-EEGX, N-EEGXOLT2020-01-22
266201228232610K191249CARESCAPE B450MHX2020-01-24
266201644272094K191149CARESCAPE B650MHX2020-01-21
266201456645970K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOCCK2019-05-01
266201699394344K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesCCK2017-08-17
266201411762255K150298Entropy Module, E-ENTROPY-01OLW2015-11-12
266202053053648K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXCCK2015-07-17
266201739806059K133622MAC 2000 ECG ANALYSIS SYSTEMDPS2014-01-23
266201389359552K133576MONITOR B40MHX2014-02-21
266201534751495K132696TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSORDQA2013-09-27
266201728219442K132533CARESCAPE MONITOR B450MHX2013-12-04
266201507009519K132528E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIESDXG2014-01-16
266201389272777K131414CARESCAPE MONITOR B850MHX2013-08-28
266201164650539K131223CARESCAPE MONITOR B650MHX2013-08-28
266201592817180K123195CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIESCCL2013-02-28
266202013199109K103802TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSORDQA2011-08-02
266201318534575K103765MAC 600 RESTING ECG ANALYSIS SYSTEMDPS2011-05-17
266201687408750K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQK2011-02-16
266201140050904K103129ENTROPY EASYFIT SENSORGWQ2011-07-19
266202058851185K102389NAVIGATOR APPLICATIONS SUITEBSZ2011-06-10
266201774546246K102239CARESCAPE MONITOR B650MHX2010-10-18
266201312466059K101871TRUSIGNAL SPO2 FINGERTIP SENSORDQA2010-10-04
266201290363034K093881TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSORDQA2010-03-12
266201222034721K092680DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS ANMHX2009-09-23
266201419416283K090892GE DATEX-OHMEDA S/5 ADU CARESTATIONBSZ2009-04-30
266201820845765K083098NAVIGATOR APPLICATIONS SUITEBSZ2009-04-01
266202015908830K082540GE ENTROPY SENSORGXY2008-11-28
266201081700892K081941NAVIGATOR APPLICATIONS SUITEBSZ2008-08-07
266202013866829K081870MASIMO COMPATIBLE SATURATION MODULE, E-MASIMODQA2008-07-31
266201046542731K071889DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWAREDSI2008-05-19
266201606006159K071097NAVIGATOR APPLICATIONS SUITEBSZ2007-10-10
266201318875922K071020DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWAREMHX2007-06-18
266202011490154K070421DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02MSX2007-03-13
266201322559864K062580GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)GXY2007-12-21
266201035789667K062576DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIESMHX2006-09-29
266201672441635K062324MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SNMHX2006-12-06
266201404236002K061994WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWAREMSX2006-08-11
266201023967241K061907MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIESOLW2008-03-27
266201578081792K061191FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2DQA2006-05-22
266201737600304K061185DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWAREMHX2006-05-15
266201271386598K052977DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIESDQK2005-11-22
266201570713863K052976DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIESDQK2006-01-13
266201873739240K052972DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3MSX2005-12-29
266202044647496K052880DATEX-OHMEDA S/5 INTERFACE MODULE E-INTCCK2005-11-02
266201741792694K052756DATEX-OHMEDA S/5 MEMORY MODULE, E-MEMMHX2005-11-01
266201482573442K052755DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSATDQA2005-10-13
266201941968841K052582DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIESCCK2005-10-14
266201893992606K052167DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIESCCK2005-09-08
266201708364251K052145DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIESOLW2005-08-23
266201734247433K051883DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.OLT2005-08-05
266201077297306K051635DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIESKOI2005-07-15
266201671790113K051634DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTIONMSX2005-07-19
266201584104158K051400DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONSMHX2006-01-20
266201069172608K051367PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000MHX2005-06-20
266201719717057K051217DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)MHX2006-02-03
266201772321260K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCCCL2005-05-25
266201915671875K050835DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIESOLW2005-05-06
266201004436223K050676GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)BSZ2005-04-12
266201016603733K050583MODEL 250 SERIES MATERNAL/FETAL MONITORHGM2005-06-21
266201571134107K043551DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIESMHX2005-02-18
266202033421110K043276DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULEMHX2004-12-23
266201643011490K042771GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3MSX2004-10-15
266201302518311K041790DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWAREMHX2004-07-23
266201371159883K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500DPZ2004-09-02
266201958507885K033078DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWAREMSX2003-10-29
266201644138831K031781DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIESMHX2003-06-25
266201145598779K023459DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIESOLW2003-01-13
266201482889896K021955TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIESDQA2002-10-08
266202015946633K013389DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIESOLW2002-01-10
266201082967640K012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESMLD2001-09-14
266201789909332K011000TRAM 2001 MODULEMHX2001-06-29
266201773827373K001688DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETERDQA2000-06-30
266201220991409
266201683504573
266201692482004
266201629987202
266201825048834
266202040995037

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX302026-09-01
DQA92013-09-27
CCK72021-10-21
OLW62015-11-12
BSZ62011-06-10
MSX62007-03-13
DQK42023-12-13
DPS42014-01-23
MWI22024-03-20
OLT22020-01-22
CCL22013-02-28
GXY22008-11-28
MLD22001-09-14
DXG12014-01-16
GWQ12011-07-19
DSI12008-05-19
KOI12005-07-15
HGM12005-06-21
DPZ12004-09-02
DRT11998-11-03
BZL11993-11-24
CAN11992-05-27

PMN#

GUDID#

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